Trial of Terbutaline for the Treatment of Status Asthmaticus in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2006-10-31

Brief Summary

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Although widely used for the treatment of pediatric status asthmaticus, intravenous terbutaline has potentially significant side effects; may not improve outcomes; and may increase Intensive Care Unit (ICU) length of stay. This study is designed to test the efficacy of intravenous terbutaline for the treatment of status asthmaticus by adding intravenous terbutaline or placebo to standard asthma treatment. The dose of terbutaline or placebo will be titrated according to severity of illness as quantified by a validated clinical asthma score. Differences in outcomes between the study groups, such as length of stay, hospital costs, and lung function will be compared.

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Detailed Description

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Conditions

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Status Asthmaticus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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terbutaline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Admission to the Connecticut Children's Medical Center (CCMC) Pediatric Intensive Care Unit (PICU) with a primary admission diagnosis of status asthmaticus
* Modified Pulmonary Index Score (MPIS) of greater than or equal to 12
* Age between birth and 18 years old

Exclusion Criteria

* Pre-existing cardiac or pulmonary disease
* Existing respiratory failure (requiring invasive or non-invasive mechanical ventilation)
* Hemodynamic or cardiovascular instability requiring inotropic support
* The patient meets one of the criteria for withdrawal from the study due to patient safety concerns

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No